The invention relates to a method for use in micro-invasive surgical procedures, wherein an instrument catheter, which is fitted with an instrument, can be slid within a close-fitting guide catheter in the body of a patient, up to an area in which a diagnostic and/or therapeutic procedure is to be performed.
The invention further relates to a device for use in micro-invasive surgical procedures, comprising a valve unit and a guide catheter that can be connected to the valve unit, into which an instrument catheter, which is fitted with an instrument, can be inserted through the valve unit.
The invention further relates to a guide catheter for a device for use in micro-invasive surgical procedures, into which an instrument catheter, which is fitted with an instrument, can be inserted through a valve unit in the device.
The invention further relates to a valve unit for a device for use in micro-invasive surgical procedures, which can be attached to a guide catheter, into which an instrument catheter, which is fitted with an instrument, can be inserted through the valve unit.
A device of this type, a guide catheter of this type, and a valve unit of this type are known in the art, for example, from DE 198 23 064 C2. The state-of-the-art device is equipped with a valve unit that can be connected to a guide catheter, in which process a dilation catheter as the instrument catheter is inserted through the valve unit into the guide catheter along a guide wire. The dilation catheter is equipped with an expandable balloon as its instrument, which, after being pushed out through the distal end of the guide catheter, can be used to treat vasoconstrictions via dilation. However, the known device, the known guide catheter, and the known valve unit that is used with a known device or a known guide catheter have the disadvantage that in order to permit a sufficient quantity of fluid, such as contrast medium for vasography, to pass through, the outer diameter of the guide catheter must be relatively large, and the outer diameter of the insertion valve must be increased accordingly, which results in a relatively high degree of trauma at the point of entry into a blood vessel.
The object of the invention is to provide a method, a device, a guide catheter, and a valve unit of the type described at the beginning that will make it possible to introduce a sufficient quantity of fluid into the vascular region to be handled or treated in diagnostic or therapeutic micro-invasive surgical procedures, while the outer diameter of the guide catheter is kept relatively small.
This object is attained in accordance with the invention with a method of the type described above, in that during the micro-invasive surgical procedure, the instrument is positioned within a bypass section, whose hydraulic cross section is larger than the cross section of the guide catheter lumen, and whose length corresponds to at least the length of the instrument; and in that a fluid is introduced into the guide catheter along the instrument that is positioned within the bypass section.
This object is attained in accordance with the invention with a device, a guide catheter, and a valve unit of the type described at the beginning, in that a hydraulic bypass section is provided, wherein, while at least part of the guide catheter wall is close-fitting for the instrument, and the lumen cross section corresponds basically to the largest cross section of the instrument, the hydraulic cross section of the bypass section is larger than the lumen cross section, and its length corresponds to at least the length of the largest cross section of the instrument.
Since the invention provides for a bypass section having a hydraulic cross section that is larger than the remaining lumen cross section of the guide catheter, at least in the area of the instrument, which may be a dilatable balloon, a vascular cutter also known as a xe2x80x9crotablator,xe2x80x9d or some other diagnostic or therapeutic instrument, part of which is larger in its cross section than a guide shaft of the instrument catheter, while the length of this hydraulic cross section corresponds to at least the length of the largest cross section of the instrument, it is now possible to introduce a quantity of fluid, such as a contrast medium that is sufficient for imaging procedures, a solution that contains some active ingredient, or gaseous carbon dioxide, into the vessel that is to be handled or treated, after the instrument has been retracted into the bypass section, even in cases in which the guide catheter lies very close to the instrument, without requiring that the instrument catheter be removed from the valve unit or retracted into the valve unit. This makes treatment through micro-invasive surgery substantially easier.
A further improvement on the device specified in the invention advantageously provides for the bypass section to be an integral part of the guide catheter.
In accordance with one embodiment of the above-mentioned further improvement on the device specified in the invention, it is advantageously provided that the bypass section is positioned in the area of the proximal end of the guide catheter.
In accordance with another embodiment of the above-named further improvement on the device specified in the invention, the bypass section, which may also be designed, for example, as a separate attachment that is integrated into the guide catheter, is positioned advantageously between the proximal end and the distal end of the guide catheter.
In one implementation of the above-named embodiment of the device specified in the invention, the bypass section is advantageously designed to have a reinforcement structure.
In a further improvement on the latter implementation of the device specified in the invention, the reinforcement structure can be expanded in conjunction with the guide catheter wall in the area of the bypass section.
In one arrangement of the bypass section between the proximal end and the distal end of the guide catheter, when a pre-expanded bypass section is used, in other words a bypass section that is expanded prior to its initial use or even during its production, and that cannot be compressed completely to correspond to the remaining outside diameter of the guide catheter, it is advantageous for the bypass section to comprise an insertion valve that is radially flexible. In this manner, when the guide catheter is passed through the insertion valve, only a brief expansion of the trauma caused by the insertion valve is produced, while the increase in the risk of hemorrhaging is insignificant.
In a further implementation of the above-named embodiment of the device specified in the invention, the bypass section is advantageously designed to have a bypass sheath that encloses the guide catheter, is sealed at its edges, and is attached to the wall of the guide catheter; and to have recesses that are built into the wall of the guide catheter near the edges of the bypass sheath.
In the latter implementation, in one form of the implementation, the recesses are essentially rounded in cross section, or are rectangular in cross section, with the lengths of the sides being essentially equal.
In a further implementation of the above-named embodiment of the device specified in the invention, the bypass section is advantageously designed to have a number of grooves that extend through the wall of the guide catheter, wherein the grooves are sealed with an outer sheath.
In one embodiment of the latter implementation of the device specified in the invention, which is equipped with the aforementioned grooves, the grooves are oriented lengthwise along the guide catheter.
In another embodiment of the latter implementation of the device specified in the invention, which is equipped with the aforementioned grooves, the grooves are designed to be coiled in a spiral.
In one device specified in the invention, in which the bypass section is positioned between the proximal end and the distal end of the guide catheter, a further embodiment advantageously provides that the wall of the guide catheter is equipped with a recessed area, in the area of the bypass section, with this recessed area extending essentially over the entire length of the bypass section, and that a collapsible bypass sheath is attached to the wall of the guide catheter, and serves to seal the recess in the wall.
In the latter embodiment it is further advantageous, for purposes of stability, for the device to contain a sheath frame unit that extends lengthwise along the guide catheter, and which can be placed in an inward, engaged position or in an outward, disengaged position.
In one implementation of the latter embodiment having a sheath frame unit, it is provided that the sheath frame unit is comprised of at least two frame braces, the outer surface area of which is small relative to the radial dimensions of the recess in the wall.
In a further implementation of the latter embodiment having a sheath frame unit, it is provided that the sheath frame unit is comprised of one frame membrane, the outer surface area of which is large relative to the radial dimensions of the recess in the wall.
In the further improvement on the device specified in the invention having a bypass section that is integrated into the guide catheter, and is positioned between the proximal end and the distal end of the guide catheter, and in the related implementations, it is advantageously provided in one exemplary embodiment that edge markers are included along the edges of the bypass section for use in imaging procedures.
In the further improvement on the device specified in the invention having a bypass section that is integrated into the guide catheter and is positioned between the proximal end and the distal end of the guide catheter, and the associated implementations of this device, it is advantageously provided in a further exemplary embodiment that visible or palpable markers are provided, which can be seen or felt during positioning of the instrument in the bypass section.
In another further improvement on the device specified in the invention, it is advantageously provided that the bypass section is designed to form a single unit together with the valve unit.
In another further improvement on the device specified in the invention, it is advantageously provided that the bypass section is designed as a torsion-proof, flexible or rigid intermediate segment that can be inserted between the guide catheter and the valve unit.
In the latter further improvement on the device specified in the invention, one embodiment advantageously provides that the intermediate segment can be connected to the guide catheter such that it can rotate.
To enable visual control, in the further developments and embodiments, with a bypass section that is positioned in the area of the proximal end of the guide catheter and is designed as a separate, intermediate unit, or as a single unit in conjunction with the valve unit, it is advantageous for the bypass section to have at least one transparent section, or to be completely transparent.
In the latter two further improvements, and in related improvements on the device specified in the invention, the length of the bypass section and the length of the valve unit through which the instrument catheter is inserted, together advantageously correspond to at least the length of a section that slides along the guide wire between the distal end of the instrument and a point of exit for the guide wire on the guide shaft.
In a further improvement on the guide catheter specified in the invention it is advantageously provided that the bypass section is positioned in the area of the proximal end of the guide catheter.
In another further improvement on the guide catheter specified in the invention, it is advantageously provided that the bypass section, which may also be designed, for example, as a separate attachment that is integrated into the guide catheter, is positioned between the proximal end and the distal end of the guide catheter.
In one implementation of the aforementioned embodiment of the guide catheter specified in the invention, the bypass section is advantageously designed to have a reinforcement structure.
In a further improvement on the latter implementation of the guide catheter specified in the invention, it is further advantageously provided that the reinforcement structure can be expanded in conjunction with the guide catheter wall in the area of the bypass section.
In a further implementation of the latter further improvement on the guide catheter specified in the invention, the bypass section is designed to have a bypass sheath that encompasses the guide catheter and is connected to the wall of the guide catheter and sealed at the edges; and to have recesses built into the wall of the guide catheter in the area of the edges of the bypass sheath.
In the latter implementation, in one exemplary embodiment the recesses are essentially rounded in cross section, or are rectangular in cross section, with the lengths of the sides being essentially equal.
In a further implementation of the latter further improvement on the guide catheter specified in the invention, it is advantageously provided that at least the bypass section is designed to have a number of grooves that extend through the wall of the guide catheter, wherein the grooves are sealed by an outer sheath.
In one implementation of a guide catheter having grooves, as specified in the invention, the grooves are oriented lengthwise along the guide catheter.
In a further implementation of a guide catheter having grooves, as specified in the invention, the grooves are coiled in a spiral.
In one guide catheter as specified in the invention, in which the bypass section is positioned between the proximal end and the distal end of the guide catheter, it is advantageously provided in one further embodiment that the wall of the guide catheter is equipped with a recessed area, in the area of the bypass section, with this recessed area extending essentially over the entire length of the bypass section, and that a collapsible bypass sheath is attached to the wall of the guide catheter, and serves to seal the recess in the wall.
In the latter embodiment of a guide catheter as specified in the invention it is further advantageous, for purposes of stability, for the device to contain a sheath frame unit that extends lengthwise along the guide catheter, and which can be placed in an inward, engaged position or in an outward, disengaged position.
In one embodiment, the sheath frame unit is comprised of at least two frame braces, the outer surface area of which is small relative to the radial dimensions of the recess in the wall.
In a further embodiment, the sheath frame unit is comprised of one frame membrane, the outer surface area of which is large relative to the radial dimensions of the recess in the wall.
In the further improvement on the guide catheter specified in the invention that has a bypass section that is positioned between the proximal end and the distal end of the guide catheter, edge markers are advantageously provided along the edges of the bypass section for use in imaging procedures.
In one embodiment of the valve unit specified in the invention, it is provided that the bypass section is designed to form a single unit with the valve unit.
In another embodiment of the valve unit specified in the invention it is provided that the bypass section is designed as an intermediate segment that is connected to the valve unit such that it can be removed.
In a further improvement on the latter embodiment of the valve unit specified in the invention, the intermediate segment can be advantageously connected to a guide catheter such that the segment can rotate.
In a further improvement on the method specified in the invention it is advantageously provided that the expanded hydraulic cross section is created by an instrument, designed to be a dilatable balloon. In this manner, the bypass section can be expanded when it is already inside the body of a patient, after being introduced through an insertion valve, which is relatively rigid, and whose size corresponds to the outer cross section of the guide catheter.